MAUDE Adverse Event Report: KARL LEIBINGER GMBH U. CO. KG DRILL-FREE NEURO SCREW; FIXATION SCREW

Model Number 25-975-05-91

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2015

Event Type  Injury  

Event Description

During insertion, the screw head broke off the shaft of the screw.The screw shaft still remains in the patient's cranial bone and was not recovered.

• Brand Name: DRILL-FREE NEURO SCREW
• Type of Device: FIXATION SCREW
• Manufacturer (Section D): KARL LEIBINGER GMBH U. CO. KG; kolbinger str. 10; muhlheim 7857 0; GM 78570
• Manufacturer (Section G): GMBH & CO. KG; kolbinger str. 10; muhlheim 7857 0; GM 78570
• Manufacturer Contact: jennifer damato - kls-martin l.p. ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 4581177
• MDR Text Key: 5336774
• Report Number: 9610905-2015-00009
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-975-05-91
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR